Trade Names:Eraxis- Injection, lyophilized powder for solution 50 mg- Injection, lyophilized powder for solution 100 mg
Inhibits formation of an essential component of fungal cell walls by inhibiting glucan synthase, an enzyme present in fungal cells.
C max ranges from 3.55 to 10.9 mg/L; AUC ranges from 42.3 to 168.9 mg•h/L.
Vd is 30 to 50 L. Protein binding is greater than 99%.
Undergoes slow chemical degradation at physiologic temperature and pH. Anidulafungin is not a substrate, inducer, or inhibitor of CYP isozymes.
Cl is 0.84 to 0.78 L/h; elimination half-life is 43.2 to 50.3 h. Approximately 30% excreted in feces over 9 days and less than 1% excreted in urine.
Dosage adjustments are not necessary based on degree of renal insufficiency, including hemodialysis.Hepatic Function Impairment
Dosage adjustment not necessary based on mild, moderate, or severe hepatic insufficiency.Elderly
Dosage adjustments not necessary for elderly patients.Gender
Dosage adjustments not necessary based on gender.Race
Dosage adjustments not necessary based on race.HIV status
Dosage adjustments not necessary based on HIV status, including coadministration of antiretroviral therapy.
Treatment of esophageal candidiasis, candidemia, and other forms of Candida infections.
Hypersensitivity to echinocandins or any component of the product.
IV Single 200 mg loading dose on day 1 followed by 100 mg/day thereafter, generally for at least 14 days after the last positive culture.Esophageal CandidiasisAdults
IV Single 100 mg loading dose on day 1 followed by 50 mg/day thereafter for a minimum of 14 days and at least 7 days following resolution of symptoms.
Store unreconstituted vials and companion vials at 59° to 86°F. Do not freeze.
Store reconstituted solution at 59° to 86°F. Do not refrigerate or freeze. The reconstituted solution must be further diluted to an infusion solution and administered within 24 h.
Store the infusion solution at 59° to 86°F. Do not refrigerate or freeze.
Anidulafungin AUC may be slightly increased. No dosage adjustment is needed.
None well documented.
Atrial fibrillation, hypertension, hypotension, right bundle branch block, sinus arrhythmia, superficial thrombophlebitis, ventricular extrasystoles (less than 2%).
Convulsions, dizziness (less than 2%); headache (1%).
Angioneurotic edema, erythema, flushing, increased sweating, pruritus, urticaria (less than 2%); rash (1%).
Blurred vision, eye pain, visual disturbance (less than 2%).
Diarrhea (3%); constipation, dyspepsia, fecal incontinence, nausea, upper abdominal pain, vomiting (less than 2%).
Coagulopathy, thrombocytopenia (less than 2%); deep vein thrombosis, leukopenia, neutropenia (1%).
Cholestasis, hepatic necrosis (less than 2%).
Decreased potassium (3%); increased alkaline phosphatase, increased ALT, increased hepatic enzyme (2%); decreased magnesium and platelet count; increased amylase, bilirubin, calcium, CPK, creatinine, lipase, magnesium, platelet count, potassium, sodium, and urea; PT prolongation, QT prolongation (less than 2%); increased AST, increased gamma-glutamyl transferase (1%).
Infusion-related reaction, peripheral edema, rigors (less than 2%).
Hyperglycemia (less than 2%).
Back pain (less than 2%).
Cough (less than 2%).
Candidiasis, clostridial infection, fungemia, oral candidiasis (less than 2%).
Category C .
Safety and efficacy not established.
Monitor patients developing abnormal LFTs during use of anidulafungin for worsening hepatic function and evaluate for continued therapy.
Generally well tolerated. Transient, asymptomatic transaminase elevations have been reported.
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